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Federal Circuit Hears Oral Arguments for Myriad Gene Patent Case

By Elina Saviharju – Edited by Esther Kang
Ass’n for Molecular Pathology v. USPTO, No. 2010-1406 (Fed. Cir. Apr. 4, 2011)
Oral Argument Recording

The Court of Appeals for the Federal Circuit heard oral arguments on April 4, 2011, for Ass’n for Molecular Pathology v. USPTO. The court focused on the issues of jurisdiction and patent-eligible subject matter under 35 U.S.C. §101, although it also briefly addressed the nature of the process claims.

The Digest has covered the earlier course of the proceedings on several occasions. The oral arguments before the court have also been discussed in Patent Docs, PatentlyO and by the Electronic Frontier Foundation, among others. 

The dispute is over the BRCA1 and BRCA2 genes, linked to a high risk of breast or ovarian cancer. The patents at issue comprise both composition claims related to isolated DNA and process claims related to the analysis and comparison of gene sequences. On March 29, 2010, the U.S. District Court for the Southern District of New York held that the patents owned by the defendant Myriad were invalid under 35 U.S.C. §101. Judge Sweet found that the prerequisites for patentability were not met, as the composition claims covered products of nature. He also concluded that the process claims failed under the “machine or transformation” test from Bilski v. Kappos, 561 U.S. ___ (2010).

The defendants-appellants first argued that the plaintiffs-appellees lacked standing. They claimed that the case was purely hypothetical and lacked real and imminent controversy traceable to the plaintiffs.  The court was also critical of the existence of real injury and pressed the plaintiffs’ attorney about the issue of standing. Judge Moore seemed concerned about widening the scope of standing and noted that allowing anyone “ready, willing, and able” to initiate action would bring about profound changes in our patent system.

Regarding the issue of patentable subject matter under 35 U.S.C. §101, the parties’ arguments revolved around the properties and function of isolated DNA compared to that of non-isolated DNA in the human body. The defendants contended that isolated DNA simply does not exist in nature without human ingenuity and research. They also noted that there are functional differences that would not exist without human effort. The court questioned the difference between isolating DNA and purifying minerals embedded in rock. Judge Lourie pointed out that the purified mineral is still the same substance whether inside or detached from the rock, whereas in isolated DNA, covalent bonds are broken. Therefore, there is a chemical separation that takes place, as opposed to mere physical separation. In contrast, the plaintiffs argued that the isolation comprises only “snipping the gene out of the body” using means well-known to a practicing scientist. They also countered the argument that isolated DNA is functionally different because it is “amenable to testing” by claiming that a kidney is still a kidney, even though it cannot be transplanted when in the body.

The U.S. Government also weighed in on the case, focusing on the issue of whether isolated DNA is patentable subject matter. It introduced a “magic microscope test” under which only compositions that do not correspond to something found in nature would be patentable. The natural molecules of isolated DNA, when examined under the magic microscope, would be found in human non-isolated DNA, making it non-patentable subject matter. Whether covalent bonds would be broken or not would be insignificant under this analysis.

The court notes the significance that its decision may have on gene patenting cases and the overall landscape of patentable subject matter. In addition to considering the issues in this case, the panel also considered whether the courtroom or the Congressional floor is the correct venue for deciding issues that implicate important policy considerations.

Elina is a LLM at Harvard Law School.

Posted On Apr - 14 - 2011 Comments Off

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